Biopsy: Participants will undergo an extra tumour biopsy procedure and venepuncture once.
Study summary
The goal of this investigator-initiated tumour profiling study is to analyse the relation between genomic alterations and the tumour immune contexture in patients with advanced melanoma and pancreatic cancer with resistance to (immuno)therapy, aiming to identify targets and approaches for future (combination) treatment. The main endpoint of this study is the number of patients for whom both tumour WGS and immune profiles could be adequately obtained.
The co-primary endpoint is the frequency of "inflamed" vs "immune excluded/desert" tumours (based on tumour infiltrating immune cells) in patients with i) NRAS/KRAS mutant vs wild-type tumours and ii) High vs low mutational tumour load.
Participants will undergo an extra tumour biopsy procedure and venepuncture once during a tumour biopsy procedure done performed as part of standard treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Diagnosis of locally advanced or metastatic cutaneous/mucosal melanoma or pancreatic cancer, meeting the following characteristics:
a. Melanoma i. Patients with histologically proven locally advanced or metastatic melanoma (stage IV), with intrinsic or acquired resistance to treatment with immune checkpoint inhibition (anti-PD1 antibody +/- ipilimumab) ii. Patients with locoregional or distant recurrence either during, or within 3 months after completion or discontinuation of (neo)adjuvant anti-PD1-based immunotherapy for stage III melanoma.
b. Pancreatic cancer i. Patients with histologically proven metastatic pancreatic cancer with progression under or after standard first-line chemotherapy with FOLFIRINOX.
2. Patients must be willing and able to provide written informed consent and be willing and able to comply with the study protocol.
3. Patients must be ≥18 years of age.
4. Metastatic or locoregional lesion of which a tumour needle biopsy can be safely obtained according to routine clinical practice.
Exclusion Criteria:
\- Patients with metastatic or locally advanced lesions which are not considered to be technically and/or safely biopsied.
Primary outcome measure(s)
Number of tumour WGS and immune profiles — through study completion, an average of 1 year number of patients for whom both tumour WGS and immune profiles could be adequately obtained
"inflamed" vs "immune excluded/desert" tumours — through study completion, an average of 1 year The co-primary endpoint is the frequency of "inflamed" vs "immune excluded/desert" tumours (based on tumour infiltrating immune cells) in patients with i) NRAS/KRAS mutant vs wild-type tumours and ii) High vs low mutational tumour load
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC, location VUmc
Amsterdam
Netherlands
More Amsterdam UMC, location VUmc trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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